UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051794 |
|---|---|
| Receipt number | R000059091 |
| Scientific Title | Evaluation of a cycle ergometer exercise in combination with neuromuscular electrical stimulation in patients following transcatheter aortic valve implantation |
| Date of disclosure of the study information | 2023/08/16 |
| Last modified on | 2024/02/01 08:10:03 |
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Basic information
Public title
Evaluation of a cycle ergometer exercise in combination with neuromuscular electrical stimulation in patients following transcatheter aortic valve implantation
Acronym
A cycle ergometer exercise in combination with neuromuscular electrical stimulation post-transcatheter aortic valve implantation
Scientific Title
Evaluation of a cycle ergometer exercise in combination with neuromuscular electrical stimulation in patients following transcatheter aortic valve implantation
Scientific Title:Acronym
A cycle ergometer exercise in combination with neuromuscular electrical stimulation post-transcatheter aortic valve implantation
Region
| Japan |
Condition
Condition
Post-transcatheter aortic valve implantation for severe aortic valve stenosis
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the safety and efficacy of a cycle ergometer exercise in combination with neuromuscular electrical stimulation in patients following transcatheter aortic valve implantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Safety: the presence or absence of any adverse events during the study
Efficacy: change in the patient' physical and motor function, which was evaluated by the score of short physical performance battery and value of the knee extension strength, during in-hospital cardiac rehabilitation post-transcatheter aortic valve implantation
Key secondary outcomes
Efficacy: change in the patient' activity of daily living, which was evaluated by the scores of functional independence measure and Barthel index, during in-hospital cardiac rehabilitation post-transcatheter aortic valve implantation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional cycle ergometer exercise in combination with neuromuscular electrical stimulation
Interventions/Control_2
Conventional cycle ergometer exercise
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will receive in-hospital cardiac rehabilitation post-transcatheter aortic valve implantation in Kurume University hospital
Key exclusion criteria
Patient post-pacemaker implantation
Patient with active bleeding and/or inflammation
Patient with motor paralysis due to central neurological disease
Patient with musculoskeletal disease to make exercise with neuromuscular electrical stimulation impossible
Patient with knee osteoarthritis to make a cycle ergometer exercise impossible
Patient with uncontrolled hypertension (casual blood pressure>180/100 mmHg) and/or arrythmia causing hemodynamic failure
Patient judged as inappropriate subject for this study by a head of research or co-investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichiro |
| Middle name | |
| Last name | Sasaki |
Organization
Kurume University School of Medicine
Division name
Division of Cardio-Vascular Medicine, Department of Internal Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume
TEL
+81-942-31-7562
sasaken@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken-ichiro |
| Middle name | |
| Last name | Sasaki |
Organization
Kurume University School of Medicine
Division name
Division of Cardio-Vascular Medicine, Department of Internal Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume
TEL
+81-942-31-7562
Homepage URL
sasaken@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center of Kurume University Hospital
Address
67 Asahi-machi, Kurume, Fukuoka
Tel
+81-942-65-3749
i_rinri@kurume-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
久留米大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2027 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059091
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| Registered date | File name |
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| Registered date | File name |
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